A Randomized Controlled Trial of a Client-centered Intervention Aiming to Improve Functioning in Daily Life After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Perceived participation
研究概览
简要总结
This is a cluster randomized controlled trial in which client-centered rehabilitation of activities of daily living (CADL) will be compared to usual rehabilitation of activities of daily living (UADL) regarding participation in activities of daily living, independence in activities of daily living and life satisfaction during the first year after stroke. In addition use of health services, caregiver burden and significant others' life satisfaction will be studied. Study design, methods and power analysis are based on our previous pilot study. Participating rehabilitation centers in the counties of Stockholm, Uppsala and Gavleborg have been randomized to supply CADL or UADL. Patients are included who are: < 3 months after stroke, dependent in at least two activities of daily living, understand instructions and referred to a participating rehabilitation unit. Data are collected at baseline, 3, 6 and 12 months. For sufficient power 280 participants will be included. In addition qualitative longitudinal studies will be performed in order to describe how CADL is integrated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •< 3 months after stroke
- •Dependent in at least two activities of daily living
- •Able to understand instructions
- •Referred to a participating rehabilitation unit.
排除标准
- •Diagnosed dementia
结局指标
主要结局
Perceived participation
时间窗: 12 months
次要结局
- Life satisfaction(3 and 12 months)
- Utilization of health care and health related services(During one year after inclusion)
- Fatigue(baseline, 3, 6 and 12 months)
- Caregiver burden(3 and 12 months)
- Self rated impact of stroke(3, 6 and 12 months)
- Activities of daily living(baseline, 3, 6 and 12 months)
- Satisfaction with care(3, 6 and 12 months)
研究者
Lena von Koch
Professor
Karolinska Institutet